- Regeneron Pharmaceuticals (Armonk, NY)
- …Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... with study teams, relevant functions and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored...areas. + Responsible for the management of GCP -compliant activities from a quality perspective in… more
- GE HealthCare (Boston, MA)
- …may develop and monitor key quality metrics to assess the effectiveness of quality management systems and report findings to senior management and ... functional QA subject matter expert + Participates in the quality management system (QMS) improvements. + Overall,...system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring… more
- CVS Health (Hartford, CT)
- …use of data, analytics, and advanced AI. We are looking for passionate and motivated Lead Data Engineers to join our growing team of engineers. We are on a mission ... for insights and reporting. + Creating and maintaining data models ensuring data quality , and efficiency. Design solutions that can scale with growing data volumes… more
- Lilly (Indianapolis, IN)
- …quality projects, ensuring alignment with GxP regulations and adherence to Lilly's Quality Management System (QMS). Responsibilities: Quality Systems and ... regulatory requirements, ensuring a comprehensive understanding of their impact on the Quality Management System (QMS), thereby facilitating the submission of… more
- Philips (Orange, OH)
- …+ You've acquired a minimum of 7+ years' experience working in FDA regulated Quality Management Systems (QMS)/Clinical environments, with a minimum of 3 years ... The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in...Studies and practices are compliant with Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good… more
- Ford Motor Company (Columbus, OH)
- …dynamic team. The ideal candidate will have a strong background in database management , Informatica, batch and ETL job processing, and a good understanding of cloud ... platforms, specifically Google Cloud Platform ( GCP ). This role involves designing, developing, and maintaining scalable...and maintain efficient, reusable, and reliable code for database management , batch jobs, and ETL processes. + Work with… more
- AbbVie (North Chicago, IL)
- …to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System. + ... in compliance with worldwide regulatory expectations and requirements. + Lead and develop strategy for global Quality ...regulations, guidelines, policies and procedures. + Plan, organize and lead multiple GCP vendor compliance audits on… more
- Novo Nordisk (Lexington, MA)
- …such as inspection host & back-room lead + Experience with clinical quality assurance, clinical trial management /monitoring or GCP Audits + ... for patients. Do you dream of using your solid GCP knowledge, process optimisation skills and quality ... Quality - will also act as the Clinical Quality Line of Business/ key project(s) lead … more
- Merck (Columbus, OH)
- … quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will ... and follow up of regulatory inspections. **Primary Responsibilities:** Operational Quality Management + Develop Risk Assessment and...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …expert medical care. **LOCATION: RTP** **Global Clinical Control & Outsourcing Project Lead I/II** Provides all outsourcing, vendor management and financial ... and then creates partnerships with external providers to enable high quality and cost-effective services to meet established timelines for clinical trials.… more
- United Therapeutics (Durham, NC)
- …include both domestic and international travel. + Develop clinical oversight plans ( Quality Management , Protocol Deviations, Vendor Oversight, etc.) to oversee ... corrective action preventative action (CAPA) and effectiveness checks using Quality Management System technology as appropriate +...the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality … more
- IQVIA (Durham, NC)
- … standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. * Manage clinical aspects of ... patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for clinical delivery of… more
- Kelly Services (Burlington, MA)
- …salary commensurate with experience. **Responsibilities:** + Drive expansion of the Quality Management System(s) in the US. + Lead and participate in third ... an experienced QA professional to support and evolve the quality management systems and processes at our...play a key role in expanding and shaping US-based Quality culture, including GCP and GLP compliant… more
- JPMorgan Chase (Vienna, VA)
- …meaningful impact in a space designed for top performers. As a Senior Lead Cybersecurity Architect at JPMorgan Chase within the Cybersecurity and Technology Controls ... for Internet of Things (IoT) Security and Endpoint Vulnerability Management team you are an integral part of a...integral part of a team that works to develop high- quality cybersecurity solutions for various software applications and platform… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and/or presentation to Study Management Teams and Senior Leadership. + Lead the development and delivery of clinical quality and compliance related ... quality in adherence to agency regulations and standards, GCP , Industry guidelines, and Olympus policies and processes for...of controlled documents (eg SOPs, Work Instructions, Templates). + Lead or assist with the implementation of Quality… more
- University of Rochester (Rochester, NY)
- …Preventative Action Program (CAPA), Internal audit program, Vendor qualification and management programs, Continuous Quality Improvement (CQI) program and the ... Quality Assurance Technical working group. As lead QSR Manager, work closely with CMSU Leadership and...International GCP /GMPs, compliance auditing, QA experience, and GCP /GMP Document Management systems. + Strong interpersonal,… more
- AbbVie (North Chicago, IL)
- …leaders and stakeholders to develop, implement, and continuously improve global and local GCP quality strategies that align with AbbVie R&D pipeline goals and ... risks across GCP activities. + Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality … more
- System One (Philadelphia, PA)
- Job Title: Lead Auditor, Audit and Quality Control Type: Direct Hire/Permanent Schedule : Hybrid 2-3 days onsite in Philadelphia Experience * Must have ... experience in GCP auditing for clinical trials. * A minimum of... * Experience with NCTN clinical trial operations, data management , audit, and quality assurance is preferred.… more
- Stratus Solutions (Hanscom AFB, MA)
- …security, deliver justice and serve the public with advanced technologies and quality analysis. We work closely with agencies and industry to overcome technical ... you may do on any given day): As the Lead Cloud Security Architect will have extensive experience in...cloud infrastructure and solutions in AWS, Azure, Oracle, and GCP cloud platforms hosted in FedRAMP and 959 FedRAMP+… more
- University of Michigan (Ann Arbor, MI)
- Clinical Research Coordinator Lead Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first page ... will have previous research experience in women's health, project management , recruitment, and will serve as a resource and...experience and mastery of all job duties from the CRC- Lead position on the Michigan Medicine CRC Career Ladder… more